NCT07758517

Brief Summary

This prospective, single-center observational cohort study evaluated the association between fresh gas flow rate during inhalational anesthesia and perioperative changes in lung aeration in adults undergoing elective surgery for nasal septal deviation. Participants were classified into two cohorts according to the fresh gas flow rate used during routine anesthesia care: 1 L/min or 3 L/min. The flow rate was selected independently by the attending anesthesiologist as part of routine clinical practice and was not assigned by the research protocol. Lung aeration was assessed using the modified lung ultrasound score before anesthesia, after tracheal intubation, before extubation, 15 minutes after admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit. Perioperative oxygenation, hemodynamic variables, respiratory mechanics, and early postoperative recovery findings were also recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

Fresh gas flow rateLow-flow anesthesiaInhalational anesthesiaLung ultrasound scoreLung ultrasoundPerioperative atelectasisPulmonary aerationSeptoplastyDesfluranePost-anesthesia care unit

Outcome Measures

Primary Outcomes (1)

  • Perioperative Change in Modified Lung Ultrasound Score

    Lung aeration was assessed in 12 thoracic regions, six regions in each hemithorax. Each region was scored from 0 to 3: 0 indicated normal aeration, 1 mild loss of aeration, 2 moderate loss of aeration, and 3 severe loss of aeration or consolidation. Regional scores were summed to obtain a total modified lung ultrasound score ranging from 0 to 36. Higher scores indicated greater loss of lung aeration. Changes in the total score across the perioperative time points were compared between the 1 L/min and 3 L/min fresh gas flow cohorts.

    Preoperative baseline; after tracheal intubation; before extubation; 15 minutes after PACU admission; and approximately 30 minutes after PACU admission or before PACU discharge

Secondary Outcomes (6)

  • Perioperative Peripheral Oxygen Saturation

    Preoperative baseline; after tracheal intubation; before extubation; 15 minutes after PACU admission; and approximately 30 minutes after PACU admission or before PACU discharge

  • Intraoperative Dynamic Lung Compliance

    Approximately 5 minutes after tracheal intubation and immediately before extubation

  • Intraoperative Peak Airway Pressure

    Approximately 5 minutes after tracheal intubation and immediately before extubation

  • Intraoperative Airway Resistance

    Approximately 5 minutes after tracheal intubation and immediately before extubation

  • Postoperative Pain Intensity

    At 15 minutes and approximately 30 minutes after admission to the PACU

  • +1 more secondary outcomes

Study Arms (2)

1 L/min Fresh Gas Flow Cohort

Participants who received inhalational general anesthesia with a fresh gas flow rate of 1 L/min as part of routine anesthetic care. The fresh gas flow rate was selected independently by the attending anesthesiologist and was not assigned by the research protocol. Perioperative lung aeration was evaluated using the modified lung ultrasound score.

Other: Fresh Gas Flow Rate of 1 L/min

3 L/min Fresh Gas Flow Cohort

Participants who received inhalational general anesthesia with a fresh gas flow rate of 3 L/min as part of routine anesthetic care. The fresh gas flow rate was selected independently by the attending anesthesiologist and was not assigned by the research protocol. Perioperative lung aeration was evaluated using the modified lung ultrasound score.

Other: Fresh Gas Flow Rate of 3 L/min

Interventions

During routine inhalational general anesthesia, a fresh gas flow rate of 1 L/min was used. The flow rate was selected independently by the attending anesthesiologist according to routine clinical practice and was not assigned or modified by the research protocol. This exposure was evaluated in relation to perioperative changes in the modified lung ultrasound score.

1 L/min Fresh Gas Flow Cohort

During routine inhalational general anesthesia, a fresh gas flow rate of 3 L/min was used. The flow rate was selected independently by the attending anesthesiologist according to routine clinical practice and was not assigned or modified by the research protocol. This exposure was evaluated in relation to perioperative changes in the modified lung ultrasound score.

3 L/min Fresh Gas Flow Cohort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adults aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who underwent elective septoplasty for nasal septal deviation under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital. Eligible consenting participants were observed prospectively, and their perioperative clinical and lung ultrasound data were recorded. Fresh gas flow rates were selected by the attending anesthesiologist as part of routine clinical care.

You may qualify if:

  • Adults aged 18 to 65 years
  • Scheduled to undergo elective septoplasty for nasal septal deviation under general anesthesia
  • American Society of Anesthesiologists physical status I or II
  • Body mass index of 35 kg/m² or less
  • Provided written informed consent to participate

You may not qualify if:

  • Acute respiratory tract infection within the preceding 15 days
  • Chronic pulmonary disease
  • Malignancy
  • Significant hepatic, renal, or cardiac disease
  • Limited ability to cooperate with the study assessments
  • Cerebrovascular or neuromuscular disease
  • Previous thoracic surgery
  • Chest wall deformity
  • Emergency surgery
  • History of clinically relevant allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and Reanimation

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

January 10, 2024

Primary Completion

January 10, 2025

Study Completion

April 15, 2025

Last Updated

August 11, 2026

Record last verified: 2026-08

Locations